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吲哚美辛与放射治疗预防髋臼骨折异位骨化的随机前瞻性研究

Indomethacin versus radiation therapy for prophylaxis against heterotopic ossification in acetabular fractures: a randomised, prospective study.

作者信息

Moore K D, Goss K, Anglen J O

机构信息

University of Missouri Hospital and Clinics, Columbia 65212, USA.

出版信息

J Bone Joint Surg Br. 1998 Mar;80(2):259-63. doi: 10.1302/0301-620x.80b2.8157.

Abstract

We report a prospective, randomised, blinded clinical comparison of the use of indomethacin or radiation therapy for the prevention of heterotopic ossification (HO) in 75 adults who had open reduction and internal fixation of acetabular fractures through either a Kocher-Langenbeck, a combined ilioinguinal and Kocher-Langenbeck, or an extended iliofemoral approach. Indomethacin, 25 mg, was given three times daily for six weeks. Radiation with 800 cGy was delivered within three days of operation. Plain radiographs were reviewed and given Brooker classification scores by three independent observers who were unaware of the method of prophylaxis. One patient died from unrelated causes and two were lost to follow-up, leaving 72, 33 in the radiation group and 39 in the indomethacin group, available for evaluation at a mean of 12 months (6 to 48). There was no significant difference in the two groups in terms of age, gender, injury severity score, estimated blood loss, delay to surgery, head injury, presence of femoral head dislocation, or operating time, and no complications due to either method of treatment. The final extent of HO was already present by six weeks in all patients who were followed up. Three patients in the radiation group and five who received indomethacin developed HO of Brooker grade III. Two patients in the indomethacin group developed Brooker IV changes; both had failed to receive proper doses of the drug. Cochran-Armitage analysis showed no significant difference between the two treatment groups as regards the formation of HO. Indomethacin and single-dose radiation therapy are both safe and effective for the prevention of HO after operation for acetabular fractures. Radiation therapy is, however, approximately 200 times more expensive than indomethacin therapy at our institution and has other risks.

摘要

我们报告了一项前瞻性、随机、双盲临床比较,研究对象为75例通过Kocher-Langenbeck、髂腹股沟联合Kocher-Langenbeck或扩大髂股入路进行髋臼骨折切开复位内固定的成人患者,比较吲哚美辛与放射治疗预防异位骨化(HO)的效果。吲哚美辛25毫克,每日三次,服用六周。800厘戈瑞的放射治疗在术后三天内进行。由三名不知道预防方法的独立观察者对X线平片进行评估并给出布鲁克分类评分。一名患者因无关原因死亡,两名患者失访,剩余72例可供评估,其中放射治疗组33例,吲哚美辛组39例,平均随访时间为12个月(6至48个月)。两组在年龄、性别、损伤严重程度评分、估计失血量、手术延迟时间、头部损伤、股骨头脱位情况或手术时间方面无显著差异,两种治疗方法均未引起并发症。所有接受随访的患者在六周时异位骨化的最终程度已显现。放射治疗组有3例患者、接受吲哚美辛治疗组有5例患者发生了布鲁克III级异位骨化。吲哚美辛组有2例患者出现布鲁克IV级改变;这两名患者均未接受适当剂量的药物。 Cochr an-Armitage分析显示,两组在异位骨化形成方面无显著差异。吲哚美辛和单剂量放射治疗在预防髋臼骨折术后异位骨化方面均安全有效。然而,在我们机构,放射治疗的费用比吲哚美辛治疗贵约200倍,且存在其他风险。

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